Pedometer-Based Walking Intervention on Physical Activity Among Hemodialysis Patients

Not Applicable

Completed

• Conditions: Fatigue; Physical Inactivity
• Interventions: Behavioral: traditional pedometer based walking intervention; Behavioral: gamified pedometer based walking intervention

• Registration Number: NCT05599646
• Lead Sponsor: Mansoura University

Brief Summary

Patients undergoing HD are mostly physically inactive and have reduced functional capacities compared to healthy individuals which contributes to a decreased quality of life and consequently increases the risk of mortality

Detailed Description

Physical activity has been shown to have various positive effects on HD patients . Some of the important benefits linked to exercise include an improvement in physical fitness , aerobic capacity , dialysis adequacy (measured as urea Kt/V) , quality of life , and reduced depressive symptoms .Walking can be considered as the most natural form of PA as it is easily performed by everyone except for the seriously disabled or very frail. Smartphones and their embedded computer technologies are increasingly being used to promote physical activity. Gamification presents itself as a promising approach to overcome a loss of interest, increase user engagement , raise the quality of health behaviors , and motivate users to use mHealth apps for a sustained period

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-28
• Study Start: 2022-10-31
• Study First Posted: 2022-10-31
• Primary Completion: 2023-09-30
• Status Verified: 2024-03
• Study Completion: 2025-03-30
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Inclusion criteria were 18 to less than 60 years of age,
• under- going conventional hemodialysis three times a week,
• hemodialysis period of three month or more,
• having smartphone aneroid access (second group),
• Available for telephone follow-up ,
• ability to read and write ,
• and being ambulatory,
• Patients using a cane or other assistive device will be eligible and Patients provided informed consent to participate.

Exclusion Criteria

The study will exclude patients with

• unstable angina,
• those with lower-limb amputation
• and those using wheelchairs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional pedometer group	traditional pedometer based walking intervention	-
gamified smartphone pedometer group	gamified pedometer based walking intervention	-

Primary Outcome Measures

Name	Time	Method
change in patients weekly step count	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	Step count will be assessed using a pedometer.
change in fatigue level	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	Brief Fatigue Inventory questionnaire will evaluate the level of current fatigue and usual fatigue in the last 24 hours.A score of 0 means no fatigue and a score of 10 means the highest level of fatigue. The total score of fatigue was obtained through summing up the score of questions 2e10 (nine items) and dividing by nine

Secondary Outcome Measures

Name	Time	Method
change in systolic blood pressure	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	a checklist to assess systolic blood pressure
change in respiratory rate	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	a checklist to assess respiratory rate
change in sleep quality	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	Sleep disorders will be assessed using the arabic version of the Pittsburgh Sleep Quality index (PSQI).The scores were added to yield a global PSQI score in the range 0-21, with a higher score indicating poorer sleep quality.
change in heart rate	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	a checklist to assess heart rate
change in diastolic blood pressure	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	a checklist to assess diastolic blood pressure
change in functional status	will be measured at baseline and after intervention [(after 12 weeks of walking program)]	The Short Physical Performance Battery (SPPB) is designed to measure functional status and physical performance.Each task is scored out of 4, with the scores from the three tests summed to give a total, with a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function

Trial Locations

Locations (1)

Faculty of Nursing Mansoura University; 🇪🇬 Mansoura, Egypt